Indian Council of Medical Research (ICMR) is planning to assess safety and efficacy of indigenous drug eluting latest generation stents and US FDA-approved drug eluting stent for a comparative study that may give a push to local manufacturers in the domestic stent market that is now dominated by foreign players now.

ICMR will evaluate two latest generation Indian stents against one FDA-approved stent through sponsored trial with a view to give fillip to the development of indigenous technologies, products and gather data about safety and efficacy.

Technologies have to reach the people at an affordable cost without a compromise on safety and efficacy. It is very important in the era of evidence based medicine to generate good scientific evidence so that it can be stated that indigenous products are not only cost effective but also efficacious and are of equally good standards, according to ICMR sources.

ICMR is planning to sponsor a randomized controlled, non-inferiority multi-centric clinical trial comparing the identified indigenous stents with a standard US FDA approved stent with the best  outcomes data. The results of this study will allow clinicians practicing in India to make informed decisions while choosing between the indigenous and standard FDA approved drug eluting stents.

ICMR has already asked the manufacturers to send expression of interest to take part in this sponsored trial. Besides supplying the stents free of the cost to the participating centres, the manufacturers would also support the implementation of the trial.

Drug eluting stents are now categorized as drugs as per the existing regulatory framework. But the new Drugs and Cosmetics (Amendment) Bill, 2013 which is under the consideration of the Parliament, has a separate chapter to put such medical devices into a new category with separate rules.

The domestic market of stents has been dominated by international device manufacturers like Abbott (Abbott Park, Illinois), Boston Scientific (Nattick, Massachusetts) and Medtronic (Minneapolis). These companies produce most of the three million stents used in India every year. Only few local manufacturers are into the sector.

There is also huge different in prices between the indigenous and foreign stents. Indian companies like Translumina Therapeutics produce stents and sell them at prices about 50 per cent lower than those made by international device manufacturers.